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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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GUIDANT CRM CLONMEL IRELAND VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number T165
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 02/24/2015
Event Type  Death  
Event Description

Boston scientific received information that the patient with this implantable cardioverter defibrillator (icd) died from a ¿heart attack". Reportedly the patient went to the cardiologist approximately one month ago to have wires removed. The patient had reported the device was ¿moving around and the wires were loose". According to the family member, the physician decided to wait because the device would need to be replaced soon. The patient collapsed and was ¿shaking", paramedics found no pulse and performed cpr. The pulse returned, but later the patient was pronounced dead. The medical examiner recommended that the device be interrogated. The family requested device information to determine what was wrong with the leads/device and why there was no therapy from the device. Boston scientific technical services (ts) discussed the family should work with the patient¿s physicians for the requested information and that a field representative could be paged to do an interrogation and provide that to the physicians. Additional information was received that a boston scientific field representative was called to interrogate the device at the funeral home. When the field representative arrived, he found the device had been removed during an autopsy at another facility. The funeral director had informed the daughter of this and wondered why the field representative was called to interrogate the device. The field representative did not know the cause of death or the location of the device. The daughter spoke directly to the field representative and was informed to contact the cardiologist office to help find the explanted device, and once located, it could be interrogated. Multiple attempts were made to acquire additional information and nothing further was received.

 
Manufacturer Narrative

(b)(4). As no further information concerning this report is currently available, our investigation is complete. This investigation will be updated should further information be provided.

 
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Brand NameVITALITY 2
Type of DeviceIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer (Section G)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 55112
6515824786
MDR Report Key4637809
MDR Text Key5612278
Report Number2124215-2015-04124
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/09/2010
Device MODEL NumberT165
OTHER Device ID NumberVITALITY 2 DR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/14/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/27/2015 Patient Sequence Number: 1
Treatment
0180; 4574; T127; T165
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